Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation

NCT06855758 | Active Not Recruiting

• 1 other identifier: 2025-P2-023-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective double blind randomized controlled trial. By randomizing patients undergoing kidney transplantation into a conventional catecholamine drug (dobutamine) blood pressure maintenance group and a terlipressin-complexed dobutamine group, the investigators compared the effect of intraoperative blood pressure maintenance and the dosage of the vasoactive drug, postoperative graft function, delayed graft function, and other related complications between the two groups, in order to demonstrate whether the use of terlipressin for blood pressure regulation during kidney transplantation is superior to the existing treatments.

Conditions

Kidney Transplant; Delayed Graft Function; Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

• Delayed graft function (DGF)

  Delayed graft function (DGF) was defined as the need for any dialysis treatment within the first 7 days after kidney transplantation.

  Within 7 days after kidney transplantation

Secondary Outcomes (5)

• Post-reperfusion dopamine requirement

  From graft reperfusion until the end of surgery

• Area under the curve for MAP below 100 mmHg after graft reperfusion

  From graft reperfusion until the end of surgery

• Early postoperative renal function (POD7)

  Postoperative day 7

• Serum creatinine after kidney transplantation at 3 months and 1 year

  3 months and 1 year after kidney transplantation

• Estimated glomerular filtration rate (eGFR) after kidney transplantation at 3 months and 1 year

  3 months and 1 year after kidney transplantation

Study Arms (2)

Placebo (normal saline) + Dopamine

PLACEBO COMPARATOR

Participants assigned to the placebo comparator group received protocol-directed hemodynamic management with a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Dopamine infusion was titrated according to intraoperative hemodynamic requirements and could be reduced or discontinued when clinically appropriate. During renal artery anastomosis, placebo (normal saline) was administered using the same preparation, administration procedure, and infusion rate as in the intervention group to maintain blinding.

Drug: Placebo (Normal Saline)

Terlipressin + Dopamine

EXPERIMENTAL

Participants assigned to the intervention group received protocol-directed hemodynamic management with a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Dopamine infusion was titrated according to intraoperative hemodynamic requirements and could be reduced or discontinued when clinically appropriate. During renal artery anastomosis, terlipressin was administered in addition to standard hemodynamic management.

Drug: terlipressin

Interventions

terlipressin DRUG

Patients randomized to the intervention group received terlipressin during renal artery anastomosis to achieve a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Terlipressin was prepared as 1 mg diluted to 10 mL and administered via syringe pump at 60 mL/h (approximately 10 minutes for full administration). Administration was initiated when MAP was below the target level (\<100 mmHg) before graft reperfusion and could be discontinued when MAP was considered adequately above the target level according to the investigator's clinical judgment.

Terlipressin + Dopamine

Placebo (Normal Saline) DRUG

Participants assigned to the control group received an equivalent volume of normal saline administered via syringe pump during renal artery anastomosis using the same procedure and infusion rate as the intervention group to maintain blinding.

Placebo (normal saline) + Dopamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with end-stage renal disease aged 18 years or above

You may not qualify if:

• simultaneous multiple organ transplantation
• known allergy to study medication
• known pregnancy status
• cancellation of surgery due to grafts or personal reasons
• persistent severe preoperative hypertension that may not require intraoperative supportive therapy with vasoactive medications
• any other reason that the supervising physician or the anesthesiologist on duty think the patient is not suitable for the study

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

Location

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Terlipressin; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Fushan Xue

  Department of Anesthesiology, Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 6, 2025
• Primary Completion: June 15, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after published
• Access Criteria: Investigators who submitting research proposals and signing agreements of data using with corresponding authors

Locations

CN (1)